As antimicrobial resistance continues to erode the effectiveness of existing treatments, clinical-stage biotechnology companies are racing to develop novel solutions. B2i Digital, Inc. has announced that Lakewood-Amedex Biotherapeutics Inc. (NASDAQ: LABT) is its newest Featured Company, spotlighting the company's novel Bisphosphocin® class and its upcoming Phase 2a clinical trial for infected diabetic foot ulcers (iDFUs). The announcement, made on August 25, 2026, underscores the urgent need for new antimicrobials that can overcome resistant pathogens.
David Shapiro, CEO of B2i Digital, highlighted the significance of Lakewood-Amedex's approach. "Antimicrobial resistance keeps narrowing the list of drugs that still work against all pathogens, and the compounds coming to replace them are mostly variations on mechanisms that bacteria have already learned to defeat," he said. "Lakewood-Amedex has spent years on a compound class that disrupts the bacterial membrane physically, and in laboratory work Nu-3 has demonstrated a high barrier to resistance. The company is preparing a Phase 2a trial in infected diabetic foot ulcers with one of the field’s most respected clinicians as study chair, which makes this a company investors should meet early."
The Bisphosphocin® class, developed by Lakewood-Amedex, represents a novel group of fast-acting, broad-spectrum antimicrobials. These small nucleotide derivatives are proposed to destabilize the bacterial cell membrane in a pH- and concentration-dependent manner, typically within one minute of exposure. Because the mechanism targets the membrane itself, the company reports that Nu-3 did not induce resistance in serial passage experiments and has shown broad-spectrum in vitro activity against bacteria carrying diverse resistance mechanisms, including MRSA.
Nu-3, the lead candidate, is a topically delivered gel targeting infected diabetic foot ulcers, a condition with significant global impact. The World Health Organization estimates that 830 million people live with diabetes, about a third of whom will develop a diabetic foot ulcer. Roughly half of those ulcers become infected, and 15% to 20% of infected cases involve resistant pathogens, primarily MRSA.
Lakewood-Amedex is finalizing preparation of a Phase 2a proof-of-concept study to evaluate the safety and efficacy of Nu-3 gel at three concentrations (2%, 5%, and 10%) in patients with infected diabetic foot ulcers. The study is intended to support advancement into a larger Phase 2b trial. Dose selection is based on a preclinical package reported in July, in which Nu-3 was well tolerated in an FDA-required safety study at dose levels substantially higher than those planned for Phase 2a, with very low systemic exposure and no inhibition of wound healing.
David G. Armstrong, DPM, M.D., Ph.D., Distinguished Professor of Surgery and Neurological Surgery at the Keck School of Medicine of USC, has accepted the position of Study Chair and will also serve as a Scientific Advisor on the iDFU program. His involvement lends credibility to the trial and the company's efforts.
Kelvin Cooper, Ph.D., CEO of Lakewood-Amedex, expressed optimism about the partnership with B2i Digital. "Our focus is on bringing the Bisphosphocin® class into the clinic and generating the proof-of-concept data that will define its potential in infected diabetic foot ulcers," he said. "Working with B2i Digital gives us the opportunity to explain that science, and the milestones ahead of it, to a much broader group of investors than a company at our stage would normally reach."
The company's intellectual property estate includes 72 issued patents and 29 pending applications, covering composition of matter, formulations, and processes, with principal filings running through 2038 and recent applications through 2044. Lakewood-Amedex began trading on the Nasdaq Capital Market under the symbol LABT following a direct listing in April 2026.
B2i Digital's Featured Company program aims to connect emerging companies with retail and institutional investors. The partnership is expected to raise awareness of Lakewood-Amedex's science and clinical milestones. For more information about B2i Digital, visit https://b2idigital.com. For details on Lakewood-Amedex, visit https://lakewoodamedex.com.
The implications of this announcement are significant for the biotech industry and public health. As antimicrobial resistance grows, the need for innovative treatments like Nu-3 becomes critical. If successful, Nu-3 could offer a new therapeutic option for infected diabetic foot ulcers, potentially reducing amputations and improving patient outcomes. For investors, the partnership with B2i Digital provides visibility into a promising clinical-stage company with a novel mechanism of action and a clear development pathway.
